Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1955-2019 — MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 88172

U.S. FDA — Device Enforcement · United States · 2019-04-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1955-2019
Date of alert
2019-04-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
COVIDIEN LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
8813793009
Reported risk: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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